In the Instruction for Users, supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to e.g. EN ISO 17665:2006 (for autoclavation)
Contribute to healthcare safety by having clear and validated instructions for sterilization.
Fulfill requirements in MDR.
Sterilization validation is performed by showing complete killing of minimum 106 colony forming units of, for the method, most resistant organism.
Methods and results are presented in a written report.
Please find contact information below
Medical Devices – validation of methods for sterilizing products
Chemical and biological analysis, Medical devices
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The customer prepares the test items unless otherwise agreed